FDA Goes After Unproven COVID-19 Antibody Tests

Companies selling tests will be required to submit data proving accuracy within next 10 days

MONDAY, May 4, 2020 (HealthDay News) — The U.S. Food and Drug Administration said Monday it will crack down on the fraudulent COVID-19 antibody tests that have flooded the market.

Companies selling COVID-19 antibody tests will be required to submit data proving accuracy within the next 10 days, or their products could be removed from public circulation, FDA officials said. Since mid-March, dozens of manufacturers have been allowed to sell antibody tests without providing any evidence they are accurate under the initial policy announced by the FDA. The intent of the initial policy was to support “the availability of antibody tests, which are an important tool in our fight against the coronavirus,” FDA Commissioner Stephen Hahn, M.D., explained during a media briefing. Unfortunately, many of the tests that came onto the market simply are not accurate.

A recent assessment of 14 COVID-19 antibody tests now available to consumers revealed that only three delivered consistently reliable results, according to a report issued by a team of more than 50 scientists. Many antibody tests are also being falsely advertised or inappropriately marketed, said Jeff Shuren, M.D., director of the FDA Center for Devices and Radiological Health. “Many companies are marketing them for use at home,” he said. “That was never permitted under our policy, unless authorized by the FDA.” Others are falsely claiming that their tests are FDA-approved for accuracy or that the antibody test can be used to diagnose an active case of COVID-19, the agency said.

The FDA will provide manufacturers and laboratories with guidelines for gathering the accuracy data needed to acquire an emergency use authorization (EUA). All companies with an antibody test currently on the market will need to get an EUA. “Our expectation is that those who can’t do that will remove their product from the market, and we will be working with them to help them do that,” Hahn said. To date, 12 antibody tests have been issued an EUA, including two developed by high-level diagnostic laboratories. There are more than 250 antibody tests currently being reviewed by the FDA for an EUA.

As of Monday afternoon, there were 1,177,784 COVID-19 cases and more than 68,000 deaths reported in the United States, according to Johns Hopkins University.